MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO NXT 4MM X 41MM - US; NEUROVASCULAR MECHANICAL THROMBECTOMY DEVICE FOR ACUTE ISCHEMIC STROKE TREATMENT

Model Number	90314
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/25/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported that during procedure, the subject device was detached and was left behind in a patient anatomy, resulting surgical delay.No other information was provided.
Event or Problem Description
It was reported that during procedure, the subject device was detached and was left behind in a patient anatomy, resulting surgical delay.No other information was provided.Update information: received additional information on 7-february-2023 stated that there was an attempt to retrieve the fractured fragment multiple times with snare which was unsuccessful.Update information #2: received additional information on 22-feb-2023 stated that the patient had expired, and no specific details provided.
Additional Manufacturer Narrative
Section b2 outcomes attributed to ae: updated.Section b5 executive summary: updated - received additional information on 7-february-2023 stated that there was an attempt to retrieve the fractured fragment multiple times with snare which was unsuccessful.Section d4 expiration date - updated.Section h4 manufacturing date ¿updated.Section f10/h6: health impact code grid; updated.
Event or Problem Description
It was reported that during procedure, the subject device was detached and was left behind in a patient anatomy, resulting surgical delay.No other information was provided.Update information.Received additional information on 7-february-2023 stated that there was an attempt to retrieve the fractured fragment multiple times with snare which was unsuccessful.
Additional Manufacturer Narrative
A2 gender: updated c2/d10 concomitant products grid: updated h3 device evaluated by mfg ¿updated h3 summary attached ¿ updated there are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection was performed as the core wire was seen to be broken at the distal end of the device, approx.198cm from the proximal end.The retriever shaped section and the insertion tool were not returned.The functional inspection was not required.The reported events 'retriever fracture/broken during use and un-retrieved device fragments' could not be confirmed; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The wire component of the device was returned for investigation.The device was received, decontaminated, inspected, measured, and imaged.Upon review of the returned wire there was stretching noted on the polymer jacket at the distal end, which is indicative that some stresses may have been exerted on the wire that could have contributed to the fracture.A review of the case images provided shows that prior to attempting to pull back the stent retriever, the system was intact.The microcatheter had been stripped back and the distal access catheter used was placed at a location proximal to the target area, with the retriever deployed outside the catheter.According to the report of the event, there was no resistance encountered when an attempt was made to pull back the retriever, which may indicate that the fracture occurred at a prior use step, although it is not possible to definitively make this determination.Therefore, an assignable cause of procedural factors will be assigned to the as reported 'retriever fracture/broken during use', 'un-retrieved device fragment', and as analyzed 'retriever core wire broken during use' since these issues are associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu but performance was limited due to procedural and/or anatomical factors during use.The as reported 'patient death' is a known and anticipated complication to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication was assigned to this event.
Event or Problem Description
It was reported that during procedure, the subject device was detached and was left behind in a patient anatomy, resulting surgical delay.No other information was provided.Update information.Received additional information on 7-february-2023, stated that there was an attempt to retrieve the fractured fragment multiple times with snare which was unsuccessful.Update information #2: received additional information on 22-feb-2023, stated that the patient had expired, and no specific details provided.
Additional Manufacturer Narrative
B2: outcomes attributed to ae: updated.B5: executive summary: updated.H1: type of reportable event: updated.F10/h6: health impact code grid ¿ updated.

• Brand Name: TREVO NXT 4MM X 41MM - US
• Common Device Name: NEUROVASCULAR MECHANICAL THROMBECTOMY DEVICE FOR ACUTE ISCHEMIC STROKE TREATMENT
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 16131881
• Report Number: 3012931345-2023-00006
• Device Sequence Number: 14250207
• Product Code: POL
• UDI-Device Identifier: 07613327299946
• UDI-Public: 07613327299946
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K200117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2024
• Device Model Number: 90314
• Device Catalogue Number: 90314
• Device Lot Number: 0000176376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2022
• Supplement Date Received by Manufacturer: 02/07/2023; 02/22/2023; 02/28/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 02/16/2023; 02/27/2023; 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NEURON MAX (NON STRYKER).; PHENOM 21 MICROCATHETER (NON STRYKER).
• Outcome Attributed to Adverse Event: Other; Death; Required Intervention
• Patient Sex: Male